Molecular Insight Pharmaceuticals, Inc. Q3 2008 Earnings Call Transcript

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2008-11-13 11:49:17.0

Tags: Call Transcript, Earnings, Trial, Molecular Insight Pharmaceuticals Inc., Federal Government, Investment, Financial Services, Government, Finance, Seeking Alpha, Call Transcript, Earnings, Trial, Molecular Insight Pharmaceuticals Inc., Federal Government, Investment, Financial Services, Government, Finance, Seeking Alpha

Question-and-Answer Session

Operator

Thank you, Mr. Babich. (Operator Instructions) Our first question comes from the line of Marco Crosio with Jefferies. Please proceed.

Marco Crosio - Jefferies

Good morning.

John Babich

Good morning, Marco. How are you?

Marco Crosio - Jefferies

Great. Thank you. So my question is pending positive Zemiva results, can you outline the subsequent steps and your thoughts on the pivotal trials?

John Babich

Sure. What our plan is assuming positive results is for us obviously to take a good hard look at what those results are telling us in terms of performance of the drug to obviously at that time for the plan to go down to the FDA.

We have already described or internally crafted what we think a Phase 3 would look like. Obviously, we have to incorporate the results of this trial into the fine tuning of that design and then pursue discussions with the FDA to get their buying on Phase 3 program.

Marco Crosio - Jefferies

Do you have any sense of size of trial and maybe length as well?

John Babich

The size of the trial will be probably at least the size of the current trial depending on our primary endpoints that number could go up from 500 to 700. Again, it depends on the results that we have; we find from this trial. The primary endpoint is likely to be clinical benefit, which I think drives the power of the study somewhat.

Don Wallroth

In terms of the overall time of the trial, we have learned a lot going through this current trial and we will be trying to make efficiencies everywhere we can predominantly in the area of sign enrollment.

We had a broad spectrum of institutions many of these institutions have done a great job for us. Some of them, where unable to deal with the protocol efficiently and will be looking to profile the high performance and seek out those institutions till we can get this study done as fast as we can.

Marco Crosio - Jefferies

Great .Thanks for taking my question. I am looking forward to the data at the end of the year?

John Babich

Thank you, Marco.

Operator

Our next question comes from the line of Matthew Andrews with Wachovia Capital Markets. Please proceed sir.

Matthew Andrews - Wachovia Capital Markets

Yes. Hi, good morning. Thank you for taking the question. I am calling in for Aaron, just two. Dr. Babich, first of all, can you remind us what your market research has revealed in terms of the commercial opportunity for MIBG in Europe with the revenues for compounding to treat neuroendocrine tumors and then I have a follow-up question on BMIPP.

 

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